The present invention is directed to tissue dilators. In preferred embodiments, the tissue dilator devices, methods of fabrication of tissue dilators, and the methods of use for tissue dilators are particularly advantageous for use as nasal dilators for supporting nasal tissues or dilating nasal tissues overlying nasal passages such as the valve and/or the vestibule portion of such nasal passages.
The present invention is directed to externally applied tissue dilators and methods of fabrication and use of such external tissue dilators to dilate nasal tissue of a subject. Some examples of presently known nasal dilators are disclosed in, for example, U.S. Pat. Nos. 5,476,091; 5,533,503; 5,546,929; 5,549,103; 5,553,605; 5,611,333; and 5,653,224, the entire disclosures of which are incorporated herein by reference.
The present invention relates to tissue dilator devices, methods of fabrication of tissue dilators, and methods of use for tissue dilators. In particular, the present invention relates to a wide variety of tissue dilators adapted to be coupled to a local tissue region of a nose to dilate interior nasal passages of a subject including the vestibule and/or the valve thereof. The present invention is not intended to be limited to the illustrated or described embodiments as they are intended merely to assist the reader of this disclosure in understanding the subject matter of the invention described, taught, enabled and depicted herein. For example, whether or not a single dilator device is depicted as adhered to a local tissue region of a single nose, more than one device, and different such dilator devices may couple to a single nose to create a desired level of dilation of said nose. Also, in those embodiments depicting a resilient member or region of resiliency to promote dilation more than a single such resilient member or region of resiliency may be utilized within or in conjunction with a single supporting body adhered to a local tissue region. Said resilient member(s) or regions of resiliency may be differing size, area, thickness, length or shape while still remaining within the purview and scope of the present invention. Likewise, use of one or more release layers in conjunction with pressure sensitive or other adhesives preferably used in conjunction with the inventive dilator devices of the present invention may be used to enhance the shelf life, ease of use and shipment, comfort to a user and the like as is presently known and used in the art. Furthermore, the present invention draws upon the long and continually developing art and science of extrusion for certain of the embodiments of the present invention and one of skill in such art and science will readily appreciate the applicability of certain of said embodiments to such manner of fabrication. The inventors hereof assert that an ideal manner of external nasal dilation preferably provides a lifting force orthogonal to the local tissue region, but some of the embodiments of this invention provide a tensing force (or surface tension across the plane of said local tissue region) so that a lower magnitude lifting force produces a desired amount of nasal dilation. Some of the embodiments of the present invention provide for reuse of certain components of the nasal dilators of the present invention so that other components may be reused. In these embodiments, the reuse may be only an additional reuse while others may provide for long term xe2x80x9creusexe2x80x9d of the entire nasal dilator. In some regard, the devices depicted, taught, enabled and disclosed herein are representative of entire families of new, useful and non-obvious tissue dilators having a variety of alternate embodiments. As a result of a single or a few illustrations of one or more such alternative embodiment, the remaining alternate embodiments should not be restricted, but rather are expressly covered hereby.
As for tissue dilator devices, the present invention encompasses a large variety of discrete structure, all intended to be applied externally to a subject for the purpose of dilating, or lifting, tissue adjacent to nasal passageways of the subject, including the vestibule and/or the valve of the subject so as to decrease resistance to inhalation and exhalation of said subject during respiration. The tissue dilators of the present invention include those having at least one resilient member providing a first biasing force, or restoring force, so that when mechanically coupled to dilate adjacent tissue of a subject, the dilator constantly exerts a restoring force developed to return the resilient member to an unbent state. In addition, a second (or additional) biasing force or forces may be applied in combination to assist in producing a desired dilation of tissue of a subject that acts in concert with the first biasing force to impart an additional amount of force to dilate tissue of a subject.
As for methods of fabrication of tissue dilator devices, the present invention teaches and enables those of skill in the manufacturing art to rapidly and efficiently produce the tissue dilator devices described herein. That is, in addition to existing methods and techniques for fabrication of tissue dilators, the present invention adds several new methods and techniques for fabricating tissue dilators according to the present invention.
As for methods of use of such tissue dilators, the present invention teaches and enables several inventive methods of use of tissue dilators for the devices described herein, methods of use and application of such devices to a local tissue region and methods of fabrication as well.